Clinical Trials Directory

Trials / Completed

CompletedNCT00454493

The Effect of Fish Oil Supplementation on Endothelial Function, Heart Rate Variability and Intimal Media Thickness of Patients With Coronary Artery Disease

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
71 (actual)
Sponsor
Olive View-UCLA Education & Research Institute · Academic / Other
Sex
All
Age
18 Years – 75 Years
Healthy volunteers
Not accepted

Summary

The purpose of this study is to investigate whether there is a difference in endothelial function, heart rate variability and carotid intimal media thickness in patients with coronary artery disease who are receiving fish oil therapy. One hundred patients with established coronary artery disease by coronary angiography will undergo randomization for enrollment in the study. Baseline evaluation will include assessment of brachial artery endothelial function, heart rate variability and carotid intimal media thickness. Evaluation of the endothelial function of the brachial artery will be elucidated by inflation of a blood pressure cuff around the arm for five minutes and measuring blood vessel dynamics after release of the cuff. Heart rate variability will be evaluated by 24 hour holter monitoring and analysis by standard protocol. Carotid intimal media thickness will be evaluated by ultrasound measurements guided by predetermined protocol. Patients will then be randomized to a highly purified fish oil, Omacor, 1 gram twice a day or placebo. Brachial artery ultrasound and holter monitoring will be repeated at 2 months. Carotid ultrasound will be repeated at the end of the study at 12 months.

Conditions

Interventions

TypeNameDescription
DRUGOmacor (omega-3-acid ethyl esters)

Timeline

Start date
2006-08-01
Primary completion
2008-10-01
Completion
2008-12-01
First posted
2007-03-30
Last updated
2019-03-13

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00454493. Inclusion in this directory is not an endorsement.